SPC 生产和库存豁免--第 1 部分

Marco Stief
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摘要

本文由两部分组成,分析和讨论欧盟第 2019/933 号法规引入的 SPC 制造和储存豁免的法律要求以及相关机遇和风险。2019年7月1日引入的SPC制造/储存豁免为在欧盟成立的仿制药和生物仿制药公司提供了机会,使其能够在相应SPC到期前制造和储存医药产品,以便出口到第三国或及时在欧盟市场上市。但是,与 "双极 "豁免等不同,SPC 豁免的申请取决于是否遵守特定的通知、尽职调查和标签义务。尽管 SPC 豁免已推出四年有余,但其应用在法律上仍存在相当大的不确定性,而德国和荷兰最近的法院判决则加剧了这一不确定性,而非澄清了这一不确定性。在本文的第一部分,我们将解释该法规的政策背景,并研究 SPC 豁免的地域和时间范围。文章第二部分将发表在下一期的《知识产权法律与实践杂志》第(......)卷第(......)期上,我将仔细研究放弃的实质范围和核心内容,特别是与特权行为有关的内容以及放弃的适用条件。
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SPC manufacturing and stockpiling waiver—part 1
This two-part article analyzes and discusses the legal requirements of, as well as the opportunities and risks associated with the SPC Manufacturing and Stockpiling Waiver as introduced by EU Regulation 2019/933. The introduction of the SPC Manufacturing/Stockpiling Waiver on July 1, 2019 opened up opportunities for generics and biosimilars companies established in the EU to manufacture and stockpile medicinal products before expiry of the respective SPC, either for export to third countries or for timely Day-1 market entry in the EU. But unlike, for example, the bolar exemption, application of the SPC Waiver is dependent upon compliance with specific notification, due diligence and labeling obligations. Although introduced more than four years ago, there is still considerable legal uncertainty surrounding the application of the SPC Waiver, something recent court decisions in Germany and The Netherlands have exacerbated rather than clarified. In this first part, the policy background of the Regulation is explained and the territorial and temporal scope of the SPC Waiver is examined. In the second part of the article, to be published in the next edition of the Journal of Intellectual Property Law and Practice Vol.(…) Issue (…) I will take a close look at the material scope and core components of the waiver, particularly as it relates to privileged acts and the conditions under which the waiver is applicable
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